Replacement of the radial head for degenerative, or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radiohumeral and or proximal radio-ulnar joint with:
- joint destruction or subluxation visible on x-ray
- resistance to conservative treatment
Primary replacement after fracture of the radial head
- Symptomatic sequelae after radial head resection
Revision following failed radial head arthroplasty

Device Description

The radial head implant like the predicate device includes various sizes of implants and accessories including sizers. The implant allows for replacement of the proximal radial head.

AI/ML Overview

This submission describes a medical device, the Avanta Orthopaedics Radial Head Implant, and seeks to establish its substantial equivalence to a legally marketed predicate device, the Wright Medical Swanson Titanium Radial Head Implant. It is not a study proving device meets acceptance criteria in the traditional sense of a clinical trial or performance study against pre-defined statistical endpoints for a novel device. Instead, the submission argues for substantial equivalence based on similarities in design, materials, and intended use to a device already on the market.

Therefore, many of the requested categories for a study proving device meets acceptance criteria are not directly applicable or explicitly stated in this type of 510(k) submission. However, I will extract and infer information where possible based on the provided text.

Here’s the information based on the provided 510(k) summary:

A table of acceptance criteria and the reported device performance

Since this is a substantial equivalence submission, the "acceptance criteria" are not performance metrics in the typical sense (e.g., sensitivity, specificity for a diagnostic device). Instead, the acceptance criteria are satisfied by demonstrating the new device is sufficiently similar to the predicate device in terms of design, materials, and intended use, such that it raises no new questions of safety or effectiveness. The reported "performance" is the comparison against the predicate.

Item	Acceptance Criteria (Similarity to Predicate)	Reported Device Performance (Avanta Product)
Product Name	Similar type of implant functionality	Radial Head Implant
Use	Single use	Single use
Fixation	Stem in intramedullary canal	Stem in intramedullary canal
Constraint	Non-constrained	Non-constrained
Material	Industry standard materials	Co-Cr/CpTi (predicate is Titanium)
Sizes	Comparably sized	3 sizes (1, 2, 3) (predicate has 5 sizes)
Indications for Use	Same indications for use	Same as predicate

Conclusion of Performance: The submission states, "The device and the predicate device have similar design characteristics and intended use. The new device is substantially equivalent to the predicate device." This indicates the device met the acceptance criteria for substantial equivalence.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a submission for substantial equivalence based on design and material comparison to a predicate device, not a performance study involving a test set of patient data. There is no mention of a test set, patient data, or data provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No test set or ground truth in this context. The "ground truth" for the substantial equivalence claim relies on the established safety and effectiveness of the existing predicate device and comparison by regulatory bodies.
Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set. The "adjudication" for substantial equivalence is carried out by the FDA during its review process.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/imaging device, nor is it a comparative effectiveness study involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a passive implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable to a conventional performance study. For substantial equivalence, the "ground truth" is effectively the regulatory approval and established safety and efficacy profile of the predicate device (Swanson Titanium Radial Head Implant), which has been marketed since 1994. The Avanta device is deemed safe and effective because it is substantially equivalent to the predicate.
The sample size for the training set

Not applicable. There is no training set mentioned, as this is not a machine learning or diagnostic device performance study.
How the ground truth for the training set was established

Not applicable. No training set.

Summary

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K011819

JUN 1 9 2001

510 (k) Summary

Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:

Prepared: June 7, 2001

Applicant: Avanta Orthopaedics, Inc. 9369 Carroll Park Drive, Suite A San Diego, CA 92121

Telephone: 858-452-8580 Fax: 858-452-9945 Contact: Louise M. Focht

Device Name: Device Trade Name: Device Classification: Reviewing Panel: Regulation Number Product Code: Original Predicate Device:

Radial Head Implant Radial head implant Class II Orthopedic 21 CFR 888.3170 87 KWI Swanson Titanium Radial Head Implant originally by Wright Medical which has been marketed since 1994. 2030506 9001389

Registration Number: Owner Operator Number:

Device Description:

The radial head implant like the predicate device includes various sizes of implants and accessories including sizers. The implant allows for replacement of the proximal radial head.

Indications for Use:

A vanta Orthopaedics Radial Head implant is intended for replacement of the proximal end of the radius:

Replacement of the radial head for degenerative, or post-traumatic disabilities . presenting pain, crepitation and decreased motion at the radiohumeral and or proximal radio-ulnar joint with:
- . joint destruction or subluxation visible on x-ray
- . resistance to conservative treatment
Primary replacement after fracture of the radial head
- Symptomatic sequelae after radial head resection .

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Comparison to the Original Predicate Device:

The legally marketed predicate device to which this device is substantially equivalent is the Wright Medical Swanson Titanium Radial Head Implant.

Regulatory Class: II Product Code: 87 KXE

		Table 2. Comparison of Wright Medical and Avanta radial head

Item	Avanta Product	Wright Medical Technologies
Product Name	Radial Head Implant	Swanson Titanium Radial Head
		Implant
Use	Single use	Single use
Fixation	stem in intramedulary canal	stem in intramedulary canal
Constraint	non constrained	non constrained
Material	Co-Cr/CpTi.	Titanium
Sizes	3 sizes, 1, 2, 3	5 sizes 1, 1.5, 2, 2.5, 3
Indications for use	Avanta Orthopaedics Radial Headimplant is intended for replacement ofthe proximal end of the radius:Replacement of the radial head fordegenerative, or post-traumaticdisabilities presenting pain, crepitationand decreased motion at the radio-humeral and/or proximal radio-ulnarjoint with :• joint destruction or subluxationvisible on x-ray• resistance to conservativetreatmentPrimary replacement after fracture ofthe radial headSymptomatic sequelae after radial headresectionRevision following failed radial headarthroplasty	Swanson Titanium Radial Headimplant is intended for replacement ofthe proximal end of the radius:Replacement of the radial head fordegenerative, or post-traumaticdisabilities presenting pain, crepitationand decreased motion at the radio-humeral and/or proximal radio-ulnarjoint with :• joint destruction or subluxationvisible on x-ray• resistance to conservativetreatmentPrimary replacement after fracture ofthe radial headSymptomatic sequelae after radial headresectionRevision following failed radial headarthroplasty

Similarities of the Avanta Orthopaedics Radial Head Implant and the Wright Medical Technology, Inc. Radial Head Implant include: Both devices are intended for single use only; Both devices are intended for surgical implantation longer than 30 days; Both devices are placed into the intramedullary canal of the proximal end of the radius; Both devices are made of industry standard materials. No new materials are introduced in either product; Both devices are comparably sized; Both devices have the same indications for use.

Summary:

The device and the predicate device have similar design characteristics and intended use. The new device is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three abstract human profiles facing to the right, with flowing lines suggesting movement or progress. The logo is in black and white.

Public Health Service

JUN 1 9 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Louise Focht Regulatory Affairs Department Avanta Orthopaedics, Inc. 9369 A Carroll Park Drive San Diego, California 92121

Re: K011819

Trade Name: Radial Head Implant Regulation Number: 888.3170 Regulatory Class: II Product Code: KWI Dated: June 7, 2001 Received: June 11, 2001

Dear Ms. Focht:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Louise Focht

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Bmtalceetnoth

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Devices Evaluation Center for Devices and Radiological Devices

Enclosure

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Page

510 (k) Number (If Known): Device Name: Radial Head

Indications for Use:

Avanta Orthopaedics Radial Head implant is intended for replacement of the proximal end of the radius:

Replacement of the radial head for degenerative, or post-traumatic disabilities ● presenting pain, crepitation and decreased motion at the radiohumeral and or proximal radio-ulnar joint with:
- joint destruction or subluxation visible on x-ray .
- resistance to conservative treatment .
. Primary replacement after fracture of the radial head
- Symptomatic sequelae after radial head resection .

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of General, Restorative and Neurological Devices

Prescription Use _ (Per 21 CFR 801.109)

510(k) Number Center Use K011819

(Optional Format 1-2-96)

Regulation Number and Section

§ 888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis.

(a)
Identification. An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.(b)
Classification. Class II.